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Tyrosine Kinase Inhibitor

Bezuclastinib + Sunitinib for GIST

Phase 2

Recruiting

Led By Candace Haddox, MD

Research Sponsored by Sarcoma Alliance for Research through Collaboration

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured

Prior progression on or intolerance to imatinib

Must not have

Major surgery within 4 weeks prior to the first dose of study drug, or subjects who have not recovered adequately from prior surgery

Prior exposure to bezuclastinib

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the time of first dose to the occurrence of disease progression (as accessed by mrecist v1.1) or death due to any cause prior to documented disease progression, up to 2 years..

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the combination of bezuclastinib and sunitinib in patients with GIST who have not responded well to sunitinib treatment.

Who is the study for?

This trial is for patients with Gastrointestinal Stromal Tumors (GIST) who have already tried sunitinib but their disease has progressed. Specific eligibility details are not provided, so interested individuals should inquire further to determine if they meet the inclusion and exclusion criteria.

What is being tested?

The study is testing a combination of two drugs: Bezuclastinib and Sunitinib, in people with GIST. It's an open-label, single-arm phase II trial, meaning all participants will receive the same treatment without a comparison group or placebo.

What are the potential side effects?

Potential side effects for this drug combination aren't specified here. However, common side effects from cancer treatments like these can include fatigue, nausea, diarrhea, skin issues and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had hepatitis C but have been treated and cured.

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My condition worsened or I couldn't tolerate imatinib.

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My cancer progressed despite taking sunitinib regularly.

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My scans show at least one area of cancer that can be measured.

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My hepatitis B is under control with treatment.

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My side effects from previous treatments are mild or gone.

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I am at least 18 years old.

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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had major surgery in the last 4 weeks or I've fully recovered from recent surgery.

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I have previously been treated with bezuclastinib.

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I had severe side effects from sunitinib at 25 mg daily.

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I do not have stomach or intestine problems affecting food absorption.

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I have a serious heart condition.

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I am not pregnant or nursing.

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I have brain metastases that have not been treated.

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I do not have any ongoing serious infections.

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I do not have any active bleeding except for hemorrhoids or gums.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the time of first dose to the occurrence of disease progression (as accessed by mrecist v1.1) or death due to any cause prior to documented disease progression, up to 2 years..

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the time of first dose to the occurrence of disease progression (as accessed by mrecist v1.1) or death due to any cause prior to documented disease progression, up to 2 years..

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the time of first dose to the occurrence of disease progression (as accessed by mrecist v1.1) or death due to any cause prior to documented disease progression, up to 2 years.. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To estimate the median progression free survival (mPFS)

Secondary study objectives

To describe patient-reported quality of life outcome measures.

Side effects data

From 2017 Phase 2 & 3 trial • 78 Patients • NCT01164202

31%

Platelets

28%

Neutrophiles

26%

Bilirubine

23%

Asthenia

21%

ASAT

21%

ALAT

15%

Leucocytose

13%

Hand-foot syndrome

13%

Liver failure

10%

Abdominal pain

Fever

Increase GGT

Anorexia

Encephalopathy

Arterial hypertension

Liver pain

Ascite

Phosphatases alcalines

Diarrhea

Encephalopathia

Hemoglobine

Lumbar pain

Hemoglobin

Prothrombin time

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Sunitinib

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: bezuclastinib in combination with sunitinibExperimental Treatment1 Intervention

Bezuclastinib 600 mg (tablet) administered orally daily Sunitinib 37.5 mg administered orally daily Patients will begin bezuclastinib and add sunitinib 2 weeks later. Each cycle is 28 days.

0 / 17Eligibility criteria met